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Comparative Effectiveness of Stress Tests (EXACT-COST)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01875315
First Posted: June 11, 2013
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karolina Zareba, Ohio State University
  Purpose
The primary objective of this project is to demonstrate that a new approach to cardiac stress imaging that combines treadmill exercise with cardiac magnetic resonance (CMR) provides valuable clinical information in a cost-effective manner.

Condition Intervention
Coronary Artery Disease Other: Diagnostic Cardiac Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: EXACT-COST: Exercise CMR's Accuracy for Cardiovascular Stress Testing-Comparative Effectiveness of Stress Tests

Further study details as provided by Karolina Zareba, Ohio State University:

Primary Outcome Measures:
  • Total patient direct and indirect medical costs for one year following stress testing will be less for patients undergoing stress CMR as compared to patients undergoing stress Nuclear. [ Time Frame: baseline ]
    Patients will undergo either Stress CMR or stress Nuclear testing. For each individual patient, the cost of the initial test, the subsequent follow-up costs, and the total costs over the follow-up period will be calculated. Total costs will be collected for direct medical, direct non-medical and indirect costs. Direct medical costs will include those applied for medications, imaging, invasive therapies and healthcare services; as well as costs resulting from side effects or complications from each of the testing strategies. Direct non-medical costs will include those incurred due to CAD-related illness or the need to seek care, such as caregiver costs and patient transportation costs. Indirect costs, will be defined as lost productivity due to time lost from work, early death or disability.


Enrollment: 130
Study Start Date: September 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any patient referred for stress SPECT
  • known or suspected ischemic heart disease
  • ability to perform adequate treadmill stress

Exclusion Criteria:

  • any contraindication to MRI (e.g. ferromagnetic foreign body, cerebral aneurysm clip, pacemaker/ICD, severe claustrophobia)
  • renal insufficiency (GFR < 40)
  • known allergy to gadolinium-based contrast or iodinated contrast (because of the research CTA in patients not referred for cath after 2 weeks)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875315


Locations
United States, Massachusetts
Brigham And Womens Hospital
Boston, Massachusetts, United States, 02115
United States, Ohio
The Lindner Center at the Christ Hospital
Cincinnati, Ohio, United States, 45219
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Jennifer Dickerson, MD Ohio State University
  More Information

Publications:
Responsible Party: Karolina Zareba, MD, Ohio State University
ClinicalTrials.gov Identifier: NCT01875315     History of Changes
Other Study ID Numbers: 2011H0295
First Submitted: June 5, 2013
First Posted: June 11, 2013
Last Update Posted: September 21, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases